Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA)

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  1 to 80

Critères de participation

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria:

1. Aged 1 day\* to 80 years on the day the study intervention is started
2. In-hospital or out-of-hospital CA with CPR \> 5 minutes
3. It is possible to randomize and start the iNO or sham during CPR or within 5 hours of ROC\*\*
4. Mechanically ventilated in a study site ICU

Note: \*Age 1 day is defined as 24 hours and a minimum corrected gestational age ≥ 38 weeks.

Note: \*\*ROC refers to either ROSC or ROC via extracorporeal cardiopulmonary resuscitation (E-CPR).

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unwitnessed cardiac arrest
2. Cardiac arrest due to birth asphyxia
3. Pre-arrest poor neurologic function\*
4. Already receiving iNO at the time of CA
5. Any condition or diagnosis, in the opinion of the PI, Co-Investigators, or MRPs, in which iNO would have adverse effects on physiology or where the cardiac anatomy and physiology has not yet been adequately assessed
6. Any condition or diagnosis, in the opinion of the PI, Co-Investigators, or MRPs, in which iNO would be indicated as therapy post-arrest
7. CPR duration \> 45 minutes; if less than 18 years old, in-hospital CPR duration \> 60 minutes\*\*
8. Known pregnancy\*\*\*
9. Terminal illness ʈ

Note: \* Poor neurologic function is defined as CPC ≥ 4 or PCPC ≥ 4.

Note: \*\*CPR duration is defined as total cumulative duration of CPR (i.e., if a patient has multiple arrests with CPR, the duration of these will be added); patients who undergo E-CPR will not be excluded, to maximize recruitment for this feasibility trial.

Note: \*\*\*B-HCG screening is not required for enrollment in women of reproductive age, but testing will occur as soon as possible (within 6 hours of enrollment).

Patients who are cannulated to ECMO for cardiorespiratory support will NOT be excluded a priori.

ʈ The MRP knew that the patient was dying pre-arrest